Status:
COMPLETED
Comparison of AC and PC Lenses After Vitreous Loss During ECCE
Lead Sponsor:
VA Office of Research and Development
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Objective: The standard definition of failure in cataract surgery is best corrected visual acuity of less than 20/40 at one year. The specific aim of this cooperative study was to compare the failure ...
Detailed Description
Primary Hypothesis: There is no difference in failure rate between patients receiving anterior chamber or posterior chamber intraocular lenses following vitreous loss in extracapsular cataract extract...
Eligibility Criteria
Inclusion
- The principal eligibility criterion was a visually significant lens opacity resulting in a best-corrected distance visual acuity of 20/50 or worse.
Exclusion
- Age less than 18 years
- Unwillingness to give informed consent
- Unwillingness to agree to protocol follow-up
- Visual acuity better than 20/50
- Any other ocular disease which would preclude a final postoperative visual acuity of 20/40 or better (e.g., proliferative diabetic retinopathy, flaucoma, or Fuchs' dystrophy)
- History of uveitis
- Other contraindication to an IOL
- Cataract attributable to trauma
- Patient only had one eye with potential for useful vision
- Any retinal thickening or definite hard exudates within one disk diameter of center of macula
- Patient's other eye already entered into the study.
- Patients could be screened for the study twice; once for each eye if they had a cataract in both. However, if the first procedure resulted in the patient being entered into the randomized study, the 5% NVP group, or the ICS group, then the second eye was not eligible for the study.
Key Trial Info
Start Date :
February 1 1992
Trial Type :
INTERVENTIONAL
End Date :
February 1 1998
Estimated Enrollment :
1202 Patients enrolled
Trial Details
Trial ID
NCT00453011
Start Date
February 1 1992
End Date
February 1 1998
Last Update
October 20 2015
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